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. 2015 Jan;92(1):22-27.
doi: 10.4269/ajtmh.14-0298. Epub 2014 Nov 10.

Performance of BinaxNOW G6PD deficiency point-of-care diagnostic in P. vivax-infected subjects

Performance of BinaxNOW G6PD deficiency point-of-care diagnostic in P. vivax-infected subjects

Lyda Osorio et al. Am J Trop Med Hyg. 2015 Jan.

Abstract

Accurate diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency is required to avoid the risk of acute hemolysis associated with 8-aminoquinoline treatment. The performance of the BinaxNOW G6PD test compared with the quantitative spectrophotometric analysis of G6PD activity was assessed in 356 Plasmodium vivax-infected subjects in Brazil, Peru, Thailand, and India. In the quantitative assay, the median G6PD activity was 8.81 U/g hemoglobin (range = 0.05-20.19), with 11 (3%) subjects identified as deficient. Sensitivity of the BinaxNOW G6PD to detect deficient subjects was 54.5% (6 of 11), and specificity was 100% (345 of 345). Room temperatures inadvertently falling outside the range required to perform the rapid test (18-25°C) together with subtlety of color change and insufficient training could partially explain the low sensitivity found. Ensuring safe use of 8-aminoquinolines depends on additional development of simple, highly sensitive G6PD deficiency diagnostic tests suitable for routine use in malaria-endemic areas.

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Figures

Figure 1.
Figure 1.
Diagram of study participants. QC = quality control.
Figure 2.
Figure 2.
Distribution of G6PD activity (percentage of the normal value in the reference population) according to the quantitative assay by sex.
Figure 3.
Figure 3.
Distribution of G6PD activity according to the BinaxNOW G6PD results.

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